Extension of Phase II Therapeutic Trial With a Humanized Non-Mitogenic CD3 (ChAgly CD3) Monoclonal Antibody in Recently Diagnosed Type 1 Diabetic Patients

This study has been completed.

Sponsors and Collaborators:	AZ-VUB Katholieke Universiteit Leuven Universiteit Antwerpen Erasme University Hospital
Information provided by:	AZ-VUB
ClinicalTrials.gov Identifier:	NCT00627146

Purpose

Compared to placebo, treatment with ChAgly CD3 has a beneficial effect on preservation of beta cell function and metabolic outcome in type 1 diabetic patients with recent clinical onset of disease that persists until 48 months after administration.

The investigators also hypothesize that in type 1 diabetic patients with recent clinical onset of disease compared to placebo, ChAgly CD3 will be safe and well tolerated between 18 and 48 months after administration, based on assessment of clinical and laboratory adverse events.

Condition	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: ChAgly CD3 Drug: Placebo	Phase II

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Extension of Phase II Therapeutic Trial With a Humanized Non-Mitogenic CD3 (ChAgly CD3) Monoclonal Antibody in Recently Diagnosed Type 1 Diabetic Patients

Further study details as provided by AZ-VUB:

Primary Outcome Measures:

The difference in change in daily insulin need between baseline and month 48, between placebo and ChAgly CD3 treated patients [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Enrollment:	80
Study Start Date:	June 2000
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Placebo Comparator	Drug: Placebo 6 days
A: Active Comparator ChAgly CD3	Drug: ChAgly CD3 6 days treatment 8mg/d intravenous

Eligibility

Ages Eligible for Study:	12 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with Type 1 diabetes mellitus included in the phase II therapeutic trial with a humanized non-mitogenic CD3 monoclonal antibody (ChAgly CD3) at time of clinical diagnosis and who agree and are likely to comply with the investigator's instructions

Exclusion Criteria:

Any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the patient
Use of illicit drugs or over consumption of alcohol (> 3 beers/day)
Being legally incapacitated, having significant emotional problems at the time of the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627146

Locations

Belgium
Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL
Leuven, Belgium, 3000
Universitair Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB
Brussels, Belgium, 1090
Hopital Erasme
Brussel, Belgium
Universitair Ziekenhuis Antwerpen
Antwerpen, Belgium
Germany
Hopital Schwabbing
Munich, Germany

Sponsors and Collaborators

AZ-VUB

Katholieke Universiteit Leuven

Universiteit Antwerpen

Erasme University Hospital

Investigators

Principal Investigator:

Bart Keymeulen, MD,PhD

Universitair Ziekenhuis Brussel

More Information

Publications:

Keymeulen B, Vandemeulebroucke E, Ziegler AG, Mathieu C, Kaufman L, Hale G, Gorus F, Goldman M, Walter M, Candon S, Schandene L, Crenier L, De Block C, Seigneurin JM, De Pauw P, Pierard D, Weets I, Rebello P, Bird P, Berrie E, Frewin M, Waldmann H, Bach JF, Pipeleers D, Chatenoud L. Insulin needs after CD3-antibody therapy in new-onset type 1 diabetes. N Engl J Med. 2005 Jun 23;352(25):2598-608.

Responsible Party:	Universitair Ziekenhuis Brussel ( Bart Keymeulen )
Study ID Numbers:	BK-AntiCD3-02
Study First Received:	February 22, 2008
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00627146
Health Authority:	Germany: Ethics Commission

Keywords provided by AZ-VUB:

Diabetes Mellitus, type 1
ChAgly CD3

Study placed in the following topic categories:

Antibodies, Monoclonal
Antibodies
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009